| CTRI Number |
CTRI/2010/091/000107 [Registered on: 09/09/2010] |
| Last Modified On: |
21/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of ZYH1 in patients with high triglyceride levels in HIV associated lipodystrophy. .[Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS VII)]. |
Scientific Title of Study
Modification(s)
|
A prospective, multi-centric, open-label, single arm study to evaluate the safety and efficacy of 4mg of ZYH1 in hypertriglyceridemia in HIV associated lipodystrophy |
| Trial Acronym |
NA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ZYH1.09.003.01.PROT,Version 1.0 dated 09/03/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr R H Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House,2nd Floor
Plot No. 360, TPS 5, Service road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186052 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr RH Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House
Plot No. 360, TPS 5, Service road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186052 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr R H Jani |
| Designation |
Sr. Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House,2nd Floor Plot No. 360, TPS 5, Service road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186052 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cadila Healthcare Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Limited Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road CrossingVile Parle (E) Mumbai-400057, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alka Deshpande |
Grant Medical College & Sir J J Gr. of Govt. Hospital |
2nd Floor, Main Building,Byculla-400008
Mumbai
MAHARASHTRA |
02223703696
alakadeshpande@rediffmail.com |
| Dr. Harsh Toshniwal |
IDTM CLINIC |
402, Gala Business Centre, Near Rajhans Society, Saint Xaviour?s College Corner Road,On H.L Commerce College Road, Off. C.G Road, Navrangpura-380006
Ahmadabad
GUJARAT |
9825249566
idtmclinic@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr.Alaka Deshpande,Instituitional Ethics Committee JMC, Mumbai |
Approved |
| Dr.Harsh Toshniwal,Independent Ethics Committee - Aditya, Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Hypertriglyceridemia in HIV associated lipodystrophy, (1) ICD-10 Condition: E781||Pure hyperglyceridemia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
ZYH1 |
Dose -4mg
Frequency-Once daily
Route-Oral |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18- 65 years
Subjects should have confirmed diagnosis of HIV 1 and on highly active antiretroviral therapy (HAART) for at last 18 months.
On stable ART regimen for at least 8 weeks prior to inclusion in the study and ART regimen not expected to change in next 3 months.
Subjects clinically diagnosed as HIV Lipodystrophy (at least 1 moderate or severe Lipodystrophy feature identified by doctor and patient, except isolated abdominal obesity)
Triglycerides between 200 - 500 mg%
Subject has given informed consent for participation in this trial
Subjects whose CD4 count is > 50/mm3
|
|
| ExclusionCriteria |
| Details |
Subjects on insulin and/or glitazone / glitazar therapy
Pregnancy and lactation
Subjects with history of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2.5 times of upper limits of normal or Bilirubin more than 2 times UNL
Renal dysfunction (serum creatinine > 2 mg%)
Subjects with history of gall stone.
Subjects with history of Cardiac failure.
Subjects with history of myopathies or evidence of active muscle diseases or CPK ≥10 times UNL
Subject with history of alcohol and/or drug abuse
History of allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
History of active Opportunistic infection in last three months.
History of malignancy or active neoplasm.
Any active hormonal disease and/or hormonal treatment that may affect the outcomes of interest such as clinically overt hypo/hyperthyroidism, hypogonadism, hypercortisolism, or treatment with steroids or growth hormone.
Hemoglobin below 9 g/dl or Total leukocyte count below 1000/mm3 or Platelet count below 50,000/mm3
Participation in any other clinical trial in past 3 months
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Triglycerides |
At 6 weeks and 12 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Low density lipoprotein (LDL),
Very low density lipoprotein (VLDL) High density lipoprotein (HDL)
Total cholesterol
Non HDL Cholesterol (Measured value) Apo(a)& Apo B
Fasting insulin and C-peptide for HOMA beta and IR. |
At 6weeks and 12 Weeks. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
21/08/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, multi-centric, open-label, single arm study to evaluate the safety and efficacy of 4mg of ZYH1 in hypertriglyceridemia in HIV associated lipodystrophy. Subjects should be clinically diagnosed as HIV Lipodystrophy with confirmed diagnosis of HIV 1 and on highly active antiretroviral therapy (HAART) for at last 18 months with Triglyceride level ranging between 200 to 500 mg% .before getting enrolled in the trial. The required sample size for this study to achieve 80% power at the 5% level of significance is a total of 50 subjects. The primary efficacy variable is the Reduction in Triglyceride (TG) at Week 6 and 12 of the treatment period compared with baseline. The change from baseline will be determined as the difference between the means for the treatment period (Week 6 and12) and the baseline. For the efficacy endpoints, treatment effect will be evaluated using an analysis of variance (ANOVA) model. Treatment effects will be estimated using the least-square means and 95% confidence intervals (CIs) from the ANOVA model. Statistical significance will be defined as a two-sided p-value <0.05. |